MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC MIS STERILE INSTRUMENT PACK MICA SCREW SYSTEM; ORTHOPEDIC TRAY

Catalog Number	57S0MI06
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that a part of the instrument broke during usage and had to be retrieved from inside the patient's foot using a stainless-steel forceps.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the instrument pack was returned for evaluation.Upon inspection, the curved and straight elevator instruments were found to be in good condition with no visible signs of damage or deformation.The double ended rasp can be seen to be broken on one end of the instrument as reported.The nature of the fracture surface exhibits signs of a brittle fracture.Furthermore, a hardness test according to rockwell on the returned device indicates the material being in accordance to the values in the material specification.Based on investigation, the root cause was attributed to a user related issue.The event was most likely caused by the application of excessive force on the device.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that a part of the instrument broke during usage and had to be retrieved from inside the patient's foot using a stainless steel forceps.

• Brand Name: MIS STERILE INSTRUMENT PACK MICA SCREW SYSTEM
• Common Device Name: ORTHOPEDIC TRAY
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20757552
• Report Number: 3010667733-2024-00896
• Device Sequence Number: 8561084
• Product Code: OJH
• UDI-Device Identifier: 00840420194664
• UDI-Public: (01)00840420194664(11)240724(17)320724(10)1793742
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 57S0MI06
• Device Lot Number: 1793742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/25/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown